K Number

Device Name

Manufacturer

BIOARTIFICIAL GEL TECHNOLOGIES (BAGTECH) INC

Date Cleared

2008-03-05

(13 days)

Product Code

FRO

Regulation Number

N/A

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

K072068,K970693,K052643,K063517

Predicate For

N/A

Intended Use

Radio BioAquaCare™ is a hydrogel wound dressing intended for the management of wounds and provides a moist environment that supports the autolytic debridement of areas of the wound that are necrotic. Radio BioAquaCare™ wound dressing provides an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. It is intended for use with dry, light, and moderately exuding partial and full-thickness wounds such as minor burns, superficial injuries, lacerations, cuts, abrasions, incisions and surgical wounds, and skin tears. The dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.

Under the direction of a health care professional, Radio BioAquaCare™ is indicated for the local management of: (1) chronic wounds such as pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, diabetic ulcers, radiation dermatitis, and (2) 2nd degree burns and donor sites.

Radio BioAquaCare™ is intended for single use only. Radio BioAquaCare™ is not intended for treatment of third degree burns.

Device Description

Radio BioAquaCare™ wound dressing is composed of the following ingredients: 1) PEG.Soy protein; 2) EDTA; 3) sodium phosphate; 4) sodium chloride; 5) water; and 6) Liquid Germall Plus® as a preservative. The preservative contained in Radio BioAquaCare™ aids in providing an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. Radio BioAquaCare™ contains up to 85% water which enables the dressing to provide a moist environment even if the wound bed is dry. Radio BioAquaCare™ will not breakdown during use, so all of the Radio BioAquaCare™ components are removed from the wound when the dressings are removed. Radio BioAquaCare™ does not include any medicinal substance, animal/human tissue, or biologics. Radio BioAquaCare™ is supplied with gauze for mechanical support, and with a backing which serves to control the rate of water evaporation from the wound dressing upon application to the wounds.

Radio BioAquaCare™ is packaged in either a single use blister packages or in plastic bag. Radio BioAquaCare™ is supplied in a variety of sizes (i.e., 5 cm x 5 cm, 8 cm x 10 cm, 8 cm x 20 cm, 8 cm x 27 cm, 8 cm x 30 cm, 8 cm x 40 cm, 8 cm x 50 cm, 10 cm x 10 cm, 10 cm x 20 cm, 10 cm x 27 cm, 10 cm x 30 cm, 10 cm x 40 cm, 10 cm x 50 cm, 15 cm x 10 cm, 15 cm x 20 cm, 15 cm x 30 cm, 15 cm x 40 cm, or 15 cm x 50 cm). Radio BioAquaCare™ is manufactured under aseptic conditions in a controlled class 100 lean room environment.

AI/ML Overview

Here is the breakdown of the acceptance criteria and study information for BAGTech's Radio BioAquaCare™, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria for the Radio BioAquaCare™ device. Instead, it relies on demonstrating technological identity and substantial equivalence to previously cleared predicate devices. The performance is described in qualitative terms, asserting that the device "functioned as intended and the performance observed was as expected" based on the validation of prior studies.

Acceptance Criterion	Reported Device Performance
Biocompatibility	Functioned as intended; performance as expected based on prior studies of BioAquaCare™.
Preservative System Effectiveness	Functioned as intended; performance as expected based on prior studies of BioAquaCare™. Ensures "effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing."
Effectiveness in Wound Management	Functioned as intended; performance as expected based on prior studies of BioAquaCare™. Provides "moist environment that supports the autolytic debridement of areas of the wound that are necrotic."
Maintenance of Integrity During Use	"Will not breakdown during use, so all of the Radio BioAquaCare™ components are removed from the wound when the dressings are removed." (This is a design characteristic, not a measured performance metric from the study described).

2. Sample size used for the test set and the data provenance

The document does not specify a distinct "test set" with a defined sample size for Radio BioAquaCare™. The performance data presented for Radio BioAquaCare™ is based on extrapolation from studies conducted on its predecessor, BioAquaCare™. The nature of these studies (in vitro and animal studies) is mentioned, but no sample sizes or data provenance (country of origin, retrospective/prospective) are provided for these underlying studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The filing does not describe a test set or the involvement of experts for ground truth establishment. The device's performance is asserted based on existing studies of a prior, technologically identical device.

4. Adjudication method for the test set

Not applicable. There is no described test set or adjudication process.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a hydrogel wound dressing, not an AI-assisted diagnostic or imaging device, so MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a hydrogel wound dressing, not an algorithm.

7. The type of ground truth used

For Radio BioAquaCare™ itself, the "ground truth" is established through technological identity to the predicate device, BioAquaCare™. The assumption is that because Radio BioAquaCare™ is "technologically identical" to BioAquaCare™, the performance observed in BioAquaCare™'s in vitro and animal studies (which would have used various experimental endpoints as their "ground truth") is directly applicable. The document does not detail the specific ground truths of those underlying studies (e.g., pathology, measured outcomes).

8. The sample size for the training set

Not applicable. This is a medical device (wound dressing), not an AI/ML model, so there is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

Not applicable. As above, there is no "training set" for this device.

Summary

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K080471
page 1 of 3

510(k) SUMMARY BAGTech's Radio BioAquaCare™

MAR - 5 2008

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, D.C., 20004 (202) 637 5794 Phone: Facsimile: (202) 637 5910

Date Prepared: February 21, 2008

Name of Device and Name/Address of Sponsor

Radio BioAquaCare™ BioArtificial Gel Technologies (BAGTech), Inc. 400 de Maisonneuve West, Suite 1156 Montreal (Quebec) H3A 1L4, Canada

Common or Usual Name

Hydrogel Wound Dressing

Classification Name

Dressing, Wound, Drug

Classification

Unclassified

Product Code

FRO

Predicate Devices

BioArtificial Gel Technologies, Inc.'s BioAquaCare™ (K072068) AcryMed Inc.'s AcryDerm Gel Wound Dressing (K970693) Ceragenix Corporation's Epiceram Skin Barrier Emulsion (K052643) Healagenics, Inc.'s Healadex-P Occlusive Dressing (K063517)

{1}------------------------------------------------

Intended Use / Indications for Use

K080471
Page 20 of 3

Radio BioAquaCare™ is a hydrogel wound dressing intended for the management of wounds and provides a moist environment that supports the autolytic debridement of areas of the wound that are necrotic. Radio BioAquaCare™ wound dressing provides an effective barner to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. It is intended for use with dry, light, and moderately exuding partial and full-thickness wounds such as minor burns, superficial injuries, lacerations, cuts, abrasions, incisions and surgical wounds, and skin tears. The dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.

Radio BioAquaCare™ is intended for single use only. Radio BioAquaCare™ is not intended for treatment of third degree burns.

echnological Characteristics

erformance Data

{2}------------------------------------------------

K080471
Page 3 of 3

Radio BioAquaCare™ is technologically identical to BAGTech's 510(k)-cleared BioAquaCare™. Various in vitro and animal studies conducted to characterize BioAquaCare™'s biocompatibility, preservative system's effectiveness, and effectiveness in the management of different types of wounds are valid for, and directly applicable to, Radio BioAquaCare™. In all instances, Radio BioAquaCare™ functioned as intended and the performance observed was as expected.

Substantial Equivalence

Radio BioAquaCare™ is as safe and effective as the predicate devices. Radio BioAquaCare™ has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. Thus, Radio BioAquaCare™ is substantially equivalent.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 5 2008

BioArtificial Gel Technologies (BAGTech), Inc. % Hogan and Hartson, L.L.P. Mr. Jonathan S. Kahan, Esq. 555 Thirteenth Street, Northwest Washington, District of Columbia 20004

Re: K080471

Trade/Device Name: Radio BioAquaCare™ Regulatory Class: Unclassified Product Code: FRO Dated: February 21, 2008 Received: February 21, 2008

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

Page 2 - Mr. Jonathan S. Kahan, Esq.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N Mullean

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

{5}------------------------------------------------

Indications for Use Statement

510(k) Number (if known):

Device Name: Radio BioAquaCare™

Indications for Use:

Radio BioAquaCare™ is intended for single use only. Radio BioAquaCare™ is not intended for treatment of third degree burns.

Prescription Use X (Part 21 C.F.R. 801 Subpart D)

AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page	1 of 1
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(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number	K080471
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Regulation Number and Section

N/A